Many of today's surgical procedures involve the use of an incise drape. The incise material is usually a clear polymeric film with an adhesive on one side which is in turn covered with a release liner. Two suppliers of incise material are the Minnesota Mining and Manufacturing Company, St. Paul, Minn., USA and T. J. Smith and Nephew Ltd., Examples of incise material can be found in U.S. Pat. Nos. 4,310,509; 4,323,557; 4,452,845; Re. 31,886 and Re. 31,887.
Most typically, incise material is used in connection with towels or surgical drapes to maintain the surgical area as clean and sterile as possible to help reduce the risk of infection. Once the surgical area of the patient has been scrubbed and treated with a antimicrobial, the surgical site is squared-off by the use of sterile towels and a surgical drape which has a fenestration of a size which is larger than the expected size of the incision. An incise material is then used to cover all or a portion of the patient's skin left exposed by the towels or the fenestration in the surgical drape or mainsheet.
One purpose in using the incise material is to help reduce the migration of germs and bacteria into the incision site. This is because, despite the cleansing of the skin, the pores still contain additional germs and bacteria which can migrate to the surface as the skin is moved and worked during the course of the surgical procedure. By covering the skin with incise material, it has been found that a lower incidence of surgical site contamination occurs.
Common practice is to take the sterile incise drape out of a disposable, protective bag (e.g., made from polyethylene) and deliver it to the sterile field in an aseptic manner. The drape typically comes in sizes as small as 13.times.18 cm (5.times.7 inches) but are usually 40.times.30 cm (16.times.12 inches) up through 90.times.120 cm (36.times.48 inches) and larger. Conventional surgical drapes usually consist of an antimicrobial film incise material covered by a one-piece silicone coated paper release liner with equal dimensions to the film so that the adhesive is protected.
Typical practice is for two people to stand on opposite sides of the operating table, each within the sterile field with sterile gloved hands. One person grips the handle portion of the drape (a 10 to 15 cm film margin free of adhesive) while the other person takes the paper liner and pulls it away from the underside exposing the adhesive. The drape is then applied to the patient at the surgical site and subsequently smoothed out and pressed onto the patient with a sterile towel. With larger drapes, this might require three or more people.
Current incise drapes are usually large and cumbersome to apply to the patient without wrinkles and without the drape sticking to itself in the process. As described above, drape application usually requires two or three people, creating a drain on operating room personnel and contributing to rising hospital costs. Applying conventional incise drapes can be a frustrating experience, even for those skilled in the art of applying incise drapes. The drape is flimsy (so as to be very conformable to the contours of the skin) with an aggressive pressure sensitive adhesive for adhesion to the skin. These two quality characteristics, when combined with the large size of incise drapes, frequently results in the application of a wrinkled drape.
It is imperative that the incise drape be wrinkle-free after it is applied, especially directly at the incision point in order for the surgeon to be able to make a clean surgical incision. Wrinkles in the drape make it difficult for the surgeon to see through to the skin (translucency and visibility are important) and, more importantly, wrinkles may not contain the bacteria on the skin as well as they should. Maintaining a sterile surface at the point of incision helps prevent surgical wound infections. Hager, K. S.; Treston Aurand, J. "A Comparison of Two Skin Preps Used in Cardiac Surgical Procedures," AORN Journal, Vol. 62, No. 3, September 1995.
See, also, U.S. Pat. Nos. 4,513,739 and 4,598,004, and British Patent No. 2,131,299, which disclose applying a dressing center first to a wound.